COLD AND HOT MEDICATED- menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Mentholatum China Pharmaceutical Co. Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Menthol - Topical analgesic temporarily relieves minor aches and pains of muscles and joints due to - arthritis - simple backache - strains - sprains - bursitis - tendonitis - bruises - cramps

Authorization status:

OTC monograph not final

Summary of Product characteristics

COLD AND HOT MEDICATED- MENTHOL PATCH
MENTHOLATUM CHINA PHARMACEUTICAL CO. LTD.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
ACTIVE INGREDIENT
Menthol 5%
PURPOS E
Menthol - Topical analgesic
US ES
temporarily relieves minor aches and pains of muscles and joints due
to
arthritis
simple backache
strains
sprains
bursitis
tendonitis
bruises
cramps
WARNINGS
WHEN USING THIS PRODUCT
use only as directed
avoid contact with eyes or on mucous membranes
do not apply to wounds or to damaged or very sensitive skin
do not bandage tightly or use with a heating pad
STOP USE AND ASK A DOCTOR IF
excessive redness or irritation is present
condition worsens
pain persist for more than 7 days
symptoms clear up and occur again within a few days
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
adults and children 12 years and over: apply patch to affected area as
needed but not more than 4
adults and children 12 years and over: apply patch to affected area as
needed but not more than 4
times daily
children under 12 years: ask a doctor
for easy application; grasp both ends of pad firmly, pull at both
ends. Stretch pad until the backing
separates. Remove protective film while applying pad directly to site
of pain.
INACTIVE INGREDIENTS
carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate
disodium, glycerin,
isopropyl myristate, partially hydrolyzed polyvinyl alcohol, partially
neutralized polyacrylates,
polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate
starch, sorbeth-60 tetraoleate,
sorbitan sesquioleate, sorbitol solution, talc, tartaric acid
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Cold and Hot Medicated Patch Menthol 5% (Large)
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Cold and Hot Medi